The regulatory background and history of phakic intraocular
lenses (PIOL) will be presented by the FDA during the Panel Meeting.Attention will be brought to FDA’s PIOL
website - http://www.fda.gov/cdrh/phakic/index.html.For a print-out of the website’s contents,
please see Attachment 1.Panel members
will be asked to recommend modifications / additions to the FDA’s PIOL website.

Many national and international consensus standards address
aspects of safety and/or effectiveness relevant to medical devices. FDA staff has been an active participant in
the development of many of these standards and has an official program devoted
to recognition of national and international consensus standards. Availability of FDA recognized standards allow
sponsors to have insight into test methods and requirements that FDA has found
acceptable, thereby streamlining the premarket review process.There are currently two PIOL standards; the
American National Standards Institute (ANSI) and the International Standards
Organization (ISO). Please see
Attachment 2 for excerpts from these standards.The standards recommendations regarding clinical trials of PIOLs for
assessment and clinical characterization of new devices will be outlined during
the meeting.Suggestions for future
revisions will be welcomed by the FDA during the Panel’s discussion. FDA will
then bring these revision recommendations to ISO and ANSI.

FDA will discuss currently available avenues of device
adverse event reporting to the FDA, including Medical Device Reporting (MDR)
and Medwatch. FDA will introduce
SightNet and explain how the safety of PIOL devices will be monitored in the postmarket
period through this cooperative network of hospitals and outpatient
centers.Please see Attachment 5 for
introductory information and a print-out from CDRH’s website about the MedSun
Product Safety Network of which SightNet is a part.You can visit the web page directly at http://www.fda.gov/cdrh/Medsun/. Panel members will be asked for their
recommendation on specific PIOL information to be collected by SightNet.

LASIK Postmarket Experience:

The FDA will present the regulatory background and history
of refractive lasers during the Panel Meeting.Currently available LASIK patient education materials will be discussed.
Specifically, an outline of typical
patient labeling (Attachment 6) and FDA’s LASIK website - http://www.fda.gov/cdrh/lasik/.For a print-out of the website’s contents,
please see Attachment 7.Panel members
will be asked to recommend modifications / additions to the FDA’s patient
labeling and LASIK Website.

FDA is currently evaluating the ANSI Refractive Laser
standard for recognition. The standard
can be recognized in its entirety, in part, or with specific additions.The standard’s recommendations regarding
clinical trials for the assessment and clinical characterization of refractive
lasers will be outlined and discussed during the meeting.Any recommendations made by the Panel members
will be considered in our recognition evaluation of this standard.The current ANSI refractive laser standard
will also be discussed. Please see the
enclosed excerpts from the standard (Attachment 8).

FDA convened a Postmarket Issue (PMI) action team to assess
aspects of the postmarket Quality of Life (QOL) experience with LASIK
devices.How the LASIK PMI Action Team
went about the assessment and the conclusions arrived at as a result will be explained.Attachment 9 contains a summary of the LASIK
PMI Action Team’s work and their conclusions.

In an effort to explore a cost-effective, efficient way to
gather clinical data on Patient Reported Outcomes (PROs) for future ophthalmic
clinical trials, FDA and the National Eye Institute (NEI) are currently
conducting a joint collaborative study. This will be the first study to compare the
computerized, web based and paper-based versions of the previously validated
questionnaires used to assess Quality of Life (QOL) in subjects with ocular
disease.This study’s protocol will be
presented to the Panel (Attachment 10).

In an effort to discuss the feasibility of a large,
postmarket, multi-centered trial to evaluate quality of life after LASIK, FDA joined
forces with the NEI, the American Society of Cataract and Refractive Surgeons
(ASCRS), and the AmericanAcademy of Ophthalmology
(AAO) to create a joint LASIK Study Task Force. The progress of this task force
will be presented to the Panel.

FDA will discuss how the postmarket safety of LASIK devices
will be monitored through the SightNet cooperative network of hospitals and
outpatient centers.Panel members will
be asked for their recommendation on specific LASIK information that should be
collected by SightNet network sites.